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A randomized, double‐blind trial of pegfilgrastim versus filgrastim for the management of neutropenia during CHASE (R) chemotherapy for malignant lymphoma
Author(s) -
Kubo Kohmei,
Miyazaki Yasuhiko,
Murayama Tohru,
Shimazaki Ryutaro,
Usui Noriko,
Urabe Akio,
Hotta Tomomitsu,
Tamura Kazuo
Publication year - 2016
Publication title -
british journal of haematology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.907
H-Index - 186
eISSN - 1365-2141
pISSN - 0007-1048
DOI - 10.1111/bjh.14088
Subject(s) - pegfilgrastim , filgrastim , medicine , neutropenia , chemotherapy , granulocyte colony stimulating factor , clinical endpoint , febrile neutropenia , oncology , randomized controlled trial , surgery
Summary Pegfilgrastim is a pegylated form of the granulocyte‐colony stimulating factor, filgrastim. Herein, we report the results of a multicentre, randomized, double‐blind phase III trial comparing the efficacy and safety of pegfilgrastim with filgrastim in patients with malignant lymphoma. Patients were randomized to receive either a single subcutaneous dose of pegfilgrastim or daily subcutaneous doses of filgrastim on day 4 after the completion of cyclophosphamide, cytarabine, etoposide and dexamethasone ± rituximab ( CHASE (R); day 1–3) chemotherapy. The primary endpoint was the duration of severe neutropenia ( DSN ), defined as the number of days with neutrophil count <0·5 × 10 9 /l in the first cycle of chemotherapy. A total of 111 lymphoma patients were randomized to either the pegfilgrastim or filgrastim group. 109 patients received either pegfilgrastim ( n = 54) or filgrastim ( n = 55). Efficacy data were available for 107 patients (pegfilgrastim: n = 53, filgrastim: n = 54). Both groups were well balanced in terms of gender, age, performance status and other variables. The mean DSN (±S.D.) was 4·5 (±1·2) and 4·7 (±1·3) d in the pegfilgrastim and filgrastim groups. No significant difference in safety was observed. This trial verified the non‐inferiority of a single subcutaneous dose of pegfilgrastim compared with daily subcutaneous doses of filgrastim, considering DSN as an indicator.